BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN RUBY ANALYZER

    MDR report key: 3821533 · Received May 20, 2014

    Report

    Report Number
    2919069-2014-00027
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    April 29, 2014
    Report Date
    April 30, 2014
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    PMA / PMN Number
    K061667
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF LABELING. THE CUSTOMER DATA WAS REVIEWED THE REPORTED ISSUE WAS SPECIFIC ONLY TO THIS PATIENTS SAMPLE; THEREFORE, THIS COMPLAINT WAS AN ISOLATED INCIDENT INVOLVING A SAMPLE WITH INTERFERING SUBSTANCES AND CONDITIONS. TRACKING AND TRENDING DID NOT IDENTIFY AN ADVERSE TREND. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE AVAILABLE INFORMATION NO PRODUCT DEFICIENCY OF THE CELL-DYN RUBY ANALYZER, LIST NUMBER 08H67-01, WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. AN EVALUATION IS IN-PROCESS.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED A FALSELY ELEVATED PLATELET COUNT WHILE USING THE CELL-DYN RUBY ANALYZER. SID (B)(6) GENERATED A RESULT OF 1105 10E9/L. THE CUSTOMER PERFORMED A MANUAL PLATELET ESTIMATE OF 190. THE SPECIMEN WAS RETESTED GENERATING THE FOLLOWING RESULTS (10E9/L): 995, 847, AND 1224. A PLATELET RESULT OF 1239 WAS GENERATED ON A CELL-DYN 3200 DIFFERENT. THE CUSTOMER INDICATED THAT THE SPECIMEN HAD ABNORMAL RBC MORPHOLOGY (BLISTER CELLS). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300520 CELL-DYN RUBY ANALYZER AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1